Abbott · 18 hours ago
Regulatory Affairs Specialist
Santa Clara, CA
Full-time
Onsite
Entry, Mid Level
$82K/yr - $141K/yr
2+ years expAbbott is a global healthcare leader that helps people live more fully at all stages of life. They are seeking a Regulatory Affairs Specialist to perform specialized work assignments and ensure compliance with regulatory agency specifications for product market entry.
BiotechnologyEmergency MedicineGeneticsHealth CareHealth DiagnosticsManufacturingMedicalMedical DeviceNutritionPharmaceutical
Responsibilities
Prepares robust regulatory applications (either for FDA or for international regulatory agencies) to achieve departmental and organizational objectives
Creates, reviews and approves engineering changes
Acts as core team member providing review and analysis of applicable regulatory guidelines and project regulatory assessments as needed
Reviews and evaluates communications to ensure communications convey all necessary detail and adhere to applicable regulatory standards including those set by the FDA or other worldwide regulatory agencies to various international affiliates
Maintains pertinent domestic and international medical device regulations to ensure submission requirements world-wide are current, up-to-date and are entered into regulatory submission data base and file systems. Ensures that information of such regulations and requirements, especially those that are new or modified, are distributed to appropriate personnel
May interface directly with FDA and other regulatory agencies
Supports the product release process by creating GTS licenses or reviewing and approving requests for product release
Reviews protocols and reports to support regulatory submissions
Supports all business segment initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements
Complies with U.S. Food and Drug Administration (FDA) and international regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors
Qualification
Required
Bachelor's degree or an equivalent combination of education and work experience
Minimum of 2 years' experience in a regulated industry (e.g., medical products, nutritionals, pharma, food). Regulatory area is preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area. Note: Higher education may compensate for years of experience
Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization. Write and edit technical documents
Work with cross-functional teams. Work with people from various disciplines and cultures
Negotiate internally
Pay strong attention to detail
Ability to leverage, manage and/or engage others to accomplish projects
Think analytically and critically
Organize and track complex information
Exercise judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions
Apply business and regulatory ethical standards
Ability to work within a team environment and accomplish projects within a fast-paced, matrixed environment
Ethical guidelines of the regulatory profession, clinical research and regulatory process
Preferred
Bachelor's Degree In science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields
Master's degree
Experience with either 510(k) applications, PMA supplements and US device regulations or with EU and other international medical device regulations and submissions
Ability to work in a highly matrixed and geographically diverse business environment
Ability to work within a team and as an individual contributor in a fast-paced, changing environment
Strong organizational and follow-up skills, as well as attention to detail
Multitasks, prioritizes and meets deadlines in timely manner
Experience working in the Medical Device industry
Regulatory Affairs Professionals Society Certification is a plus
Benefits
Free medical coverage in our Health Investment Plan (HIP) PPO medical plan
An excellent retirement savings plan with a high employer contribution
Tuition reimbursement
The Freedom 2 Save student debt program
FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree
Company
Abbott
Abbott is a healthcare company that produces diagnostic kits, medical devices, nutritional products, and branded generic medicines.
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$6.79M2011-03-15Post Ipo Debt· $0.1M
2009-03-16Post Ipo Debt· $6.69M
1980-12-12IPO
Leadership Team
Robert Ford
President & Chief Executive Officer
Mike Peterson
Senior Vice President
Recent News
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